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Tactoset® Injectable Bone Substitute is a synthetic, biocompatible material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgicallycreated osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, selfsetting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), Iohexol (C19H26J3N309) and water for injection. Tactoset is provided sterile for single use.

This document describes the FDA 510(k) premarket notification for the Tactoset® Injectable Bone Substitute. It is a medical device, specifically a resorbable calcium salt bone void filler. The information provided heavily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.

Therefore, many of the requested criteria regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this document, as it is about a different type of medical device (a bone substitute) and its premarket clearance process based on substantial equivalence.

However, I can extract information related to the performance testing and comparison for this specific device type, which serves a similar purpose of demonstrating safety and effectiveness.

Here's an analysis of the provided text based on your request, focusing on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in the typical sense of numerical thresholds for a clinical study endpoint for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "performance" is shown by comparing the subject device's properties and animal study results to those of the predicates.

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The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state.

The Integrity Implant will be made available in 2 sizes:

• 20mm X 25mm
• 25mm X 30mm

The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body.

The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure. It will be fixated at one end to the bone via fixation anchor and at the other end to the repaired tendon via suture or fixation anchor.

The provided document is a 510(k) summary for the Integrity™ Implant, a medical device for managing and protecting tendon injuries. It is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/ML device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance tests. The performance data is presented as evidence that the subject device performs comparably to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

• Animal Study (Test Set):

  • Sample Size: Forty-seven (47) skeletally mature sheep were enrolled.
  • Data Provenance: The study used an adult bilateral infraspinatus model in sheep, making it prospective animal data. The country of origin of the animal study is not specified in this document.

• No human clinical studies were conducted for this 510(k) submission, so there is no human test set data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• For the animal study, the document mentions "gross dissections and harvest," "blood work and distant organ pathology," "radiographic endpoints," and "histology results."
• While these imply expert analysis (e.g., veterinary pathologists, radiologists, histotechnologists/pathologists), the document does not explicitly state the number of experts, their qualifications, or how ground truth was established for the animal study. It only reports the findings (e.g., "Blood work and distant organ pathology were normal," "Histology results from the current study demonstrated...").

4. Adjudication Method for the Test Set:

• The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the animal study. It's typical for animal study results to be interpreted by a single or a small team of experts (e.g., a veterinary pathologist), but this detail is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a surgical implant, not an imaging analysis AI device that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No standalone (algorithm only) performance study was done. This device is a physical implant; there is no AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used:

• For the animal study, the "ground truth" was established through a combination of:
  • Direct Observation: Gross macroscopic appearance during dissection.
  • Imaging: Radiographic changes based on AP and lateral radiographs and Micro-Computed Tomography, 3T MRI scanning.
  • Biomechanical Testing: Tensile testing of the repaired rotator cuff.
  • Histopathology: Histological responses.
  • These are all objective biological and physical measurements from the animal model.

8. The Sample Size for the Training Set:

• This submission is for a physical medical device (implant), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning model development. The performance data is generated through bench and animal testing.

9. How the Ground Truth for the Training Set Was Established:

• As there is no AI/ML algorithm with a training set, this question is not applicable.

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The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.

The Integrity™ Bone Staple Fixation System consists of bone staples and a delivery instrument. The bone staple is a staple-shaped tack with barbed ends and is comprised of non-absorbable poly(ether ether ketone) [PEEK]. The bone staples are designed to provide fixation of soft tissue grafts or reinforcement meshes to bone at surgery and are used in conjunction with a Delivery instrument from Anika. The device is sterilized by radiation with a SAL of 10-9. The bone staples and delivery instruments are provided sterile for single use only. The staples are packaged in a caddy within a dual sterile packaging configuration.

The provided text describes a 510(k) premarket notification for the "Integrity™ Bone Staple Fixation System," which is a Class II medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy through multi-reader, multi-case studies or extensive standalone AI performance evaluations.

Therefore, the document does not contain the kind of information typically found in studies for AI/ML-driven diagnostic devices, such as:

• Acceptance criteria tables for AI performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets used to evaluate AI performance
• Details on data provenance for AI model development/testing (e.g., country of origin, retrospective/prospective)
• Number and qualifications of experts for ground truth establishment
• Adjudication methods for ground truth
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Training set sample sizes
• Methods for establishing training set ground truth

Instead, the submission focuses on mechanical performance testing, biocompatibility, and comparison of physical characteristics to the predicate device to demonstrate substantial equivalence.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Device Performance (Mechanical/Biocompatibility):

The document does not present a formal table of "acceptance criteria" for AI performance metrics. Instead, it describes performance testing related to the physical and biological characteristics of the bone staple. The "reported device performance" is summarized qualitatively as having "higher tensile and shear retention strength" demonstrated in mechanical performance testing, and passing biocompatibility tests.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in terms of number of cases/patients. "Performance Testing Summary" indicates mechanical, insertion/removal, biocompatibility, and bacterial endotoxin testing were performed. These tests would involve a specific number of device samples, but this detail is not provided.
• Data Provenance: Not applicable in the context of clinical image data for AI. The data provenance here refers to the source of the materials and manufactured devices used for the described non-clinical tests. No geographical or retrospective/prospective data details are relevant to this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission does not involve diagnostic image interpretation or clinical expert-established ground truth. The "ground truth" for this device is based on laboratory-measured physical properties and biological responses to materials.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No clinical expert adjudication was performed as part of this non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This device is a bone staple, not an AI-assisted diagnostic tool. The submission explicitly states: "No clinical or animal data were required to support the substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. There is no AI algorithm being evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For this device, the "ground truth" for performance is based on objective measurements derived from standardized mechanical testing protocols (e.g., tensile strength, shear strength, insertion/removal forces) and biocompatibility testing standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation) and bacterial endotoxin assays. There is no "expert consensus" or "pathology" as would be seen in diagnostic imaging.

8. The sample size for the training set:

• Not applicable. There is no AI model or "training set" involved.

9. How the ground truth for the training set was established:

• Not applicable. There is no AI model or "training set" involved.

In summary, this FDA 510(k) submission for a bone staple system is for a conventional medical device and therefore does not include any information related to AI/ML performance testing. The "study that proves the device meets the acceptance criteria" refers to a battery of non-clinical, bench-top mechanical tests and biocompatibility assays, rather than a clinical study evaluating diagnostic accuracy or reader performance.

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The Anika Tissue Tack is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.

The Anika Tissue Tack Fixation System consists of dart shaped tacks and a delivery instrument. The tissue tacks are comprised of bioabsorbable 82/18 poly(lactic-co-glycolic acid) [PLGA] and dyed with D&C Violet #2. The tissue tacks are designed to provide stable fixation of a prosthetic material or biologics to soft tissues during the healing process and are used in conjunction with a delivery instrument from Anika. The delivery instruments are comprised of surgical grade stainless steels and high temperature plastics and are designed to deliver the tissue tacks. The tissue tacks and delivery instruments are provided sterile for single use only. The tacks are packaged in a caddy within a dual sterile seal configuration.

I am sorry but this document does not contain the information requested. This document is a 510(k) summary for a medical device which describes the device, its indications for use, and its substantial equivalence to predicate devices based on non-clinical testing. It does not include information about acceptance criteria or specific studies that demonstrate the device meets those criteria in the way you have asked for (e.g., with detailed statistics on performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance).

Specifically, the document states:

• "No clinical testing was submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence for the Anika Tissue Tack Fixation System."
• The performance testing summarized includes "Mechanical retention strength, tensile & shear", "Degradation testing", "Insertion and removal evaluation", "Biocompatibility Testing", and "Bacterial endotoxin limit test". However, no specific acceptance criteria or detailed results are provided.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies for this device.

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Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process and may be combined with autogenous bone marrow. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Tactoset is an injectable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [CaHgO7], hyaluronic acid (HA), and water for injection. At a specified volume, the aqueous setting solution can be combined with autogenous bone marrow, i.e., bone marrow aspirate. Tactoset is provided sterile for single use.

The provided text describes a 510(k) premarket notification for a medical device called Tactoset. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results for the device itself. Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment are not present in the provided document.

However, based on the available information, I can extract what is present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a quantitative table with specific targets. Instead, it demonstrates "substantial equivalence" to predicate devices through various comparisons, including material composition, physical properties, mechanical testing, and an animal functional study. The closest an explicit performance comparison comes is in the animal study section:

Other aspects like mixing time, working time, setting time, sterility, and pyrogenicity are presented as characteristics that are equivalent to the predicate device, implying that the predicate's performance in these areas serves as an "acceptance criteria" through analogy.

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Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.

Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), and water for injection. Tactoset® Injectable Bone Substitute is provided sterile for single use in volumes ranging from 1cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.

This document is a 510(k) Premarket Notification for a medical device called Tactoset Injectable Bone Substitute. It aims to demonstrate that this new device is "substantially equivalent" to legally marketed predicate devices, meaning it is as safe and effective.

The provided document does not contain the detailed information necessary to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device. This 510(k) is for a bone substitute material, not an AI or imaging device. The performance testing summary explicitly states:

• "Non-clinical verification testing data submitted to demonstrate substantial equivalence included bench performance testing as follows: Pull-out testing, Bone alignment testing"
• "Pyrogenicity and bacterial endotoxin testing were performed..."
• "No animal performance testing or clinical data are included in this submission."

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these are concepts primarily applicable to the validation of AI/ML or diagnostic imaging devices, not a bone void filler.

The document does not describe the following:

1. A table of acceptance criteria and the reported device performance (in the context of an AI/ML study).
2. Sample sizes used for a test set (related to AI/ML).
3. Number of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Multi reader multi case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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SCS 17-01 is a syntheic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremites and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.

The SCS 17-01 product is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft substitute material. SCS 17-01 is composed of a dry powder and an aqueous solution (supplied in separate sterile, preloaded syringes) that must be mixed intra-operatively to form a cohesive paste prior to implantation using the supplied mixing system. The dry powder is composed of the alpha phase of tricalcium phosphate (alphaTCP) [Ca3(PO4)2], calcium [CaCO3] carbonate phosphate [Ca(H2PO4)2]. The aqueous component is composed of water for injection, sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7] and hyaluronic acid (HA). Upon mixing the cement powder and the setting solution at body temperature, a dissolution and reprecipitation reaction occurs resulting in the precipitation of a poorly crystalline hydroxyapatite. During the healing process, the bone void filler resorbs and is replaced with new bone growth. SCS 17-01 is provided sterile for single use in volumes ranging from 1cc to 4cc.

I am sorry, but the provided text does not contain information about the acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML powered medical device. The document is a 510(k) clearance letter for a bone void filler and describes its substantial equivalence to a predicate device based on bench tests, chemical and physical characterization, and an in vivo animal study. It does not refer to an AI device or any associated performance metrics or studies as described in your request.

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SCS 17-01 is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the sketal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.

SCS 17-01 is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PQ4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [CoH30], hyaluronic acid (HA), and water for injection. SCS 17-01 is provided sterile for single use in volumes ranging from 1.5cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.

The provided text describes a 510(k) premarket notification for a medical device called SCS 17-01, a resorbable calcium salt bone void filler. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria or conducting a clinical effectiveness study against a defined set of acceptance criteria in humans.

Therefore, many of the requested details, such as specific acceptance criteria for device performance in a clinical setting, human-in-the-loop studies (MRMC), or a comprehensive standalone algorithm performance, are not applicable to this type of submission. The study described is primarily pre-clinical (animal studies) and lab-based testing to show equivalence in properties and performance to existing devices.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not relevant to this type of regulatory submission:

Acceptance Criteria and Study for SCS 17-01 (K173008)

This submission is a 510(k) Premarket Notification for a Class II medical device (SCS 17-01, Product Code MQV). The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet new, standalone acceptance criteria for clinical performance that would typically be seen for novel devices or those undergoing PMA. The "acceptance criteria" here are implicitly tied to demonstrating equivalence through comparative testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on pre-clinical data and comparison to predicate devices, the "acceptance criteria" are not framed as specific clinical outcome thresholds, but rather as demonstrating similar characteristics and performance in in-vitro and in-vivo (animal) models.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Animal Study): The text mentions a "rabbit distal femoral condyle critical-sized defect model" and that "The baseline (time 0) animals provided information on the initial amount of material implanted to fill the defects. Emptv (unfilled) defects (negative control) and defects filled with autograft (positive control) were evaluated at 6 weeks and 12 weeks."
  • Sample Size: The exact number of animals or defects per group (subject device, primary predicate, negative control, positive control, time points) is not specified in the provided text.
  • Data Provenance: This was an in vivo animal study. The country of origin is not specified. It is a prospective experimental study in an animal model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not Applicable / Not Specified: For the animal study, the "ground truth" would be established by the measured outcomes (radiographic appearance, micro-CT, histology, histomorphometry, mechanical testing). While pathologists or radiologists would interpret the animal data, the number and qualifications of experts involved in analyzing the animal study endpoints are not specified in the provided text. This is not a human clinical study requiring human interpretation of medical images.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified: As this is primarily an animal study and laboratory testing, there is no mention of a human-based adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as would be common in human diagnostic imaging studies. The data points (e.g., measurements from histology, mechanical tests) would be objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: The provided text explicitly states: "No clinical data are included in this submission." An MRMC study involves human readers interpreting clinical cases, which was not performed or submitted for this device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

• No: This device is a bone void filler material, not an AI algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

• For the animal study, the ground truth was established through a combination of:
  • Histology / Histomorphometry: Direct microscopic examination of tissue and quantitative analysis of bone formation/resorption within the defect.
  • Radiography and Micro-Computed Tomography (micro-CT): Imaging modalities to visualize the implanted material and surrounding bone.
  • Mechanical Testing: Objective measurement of the strength or mechanical properties of the treated bone.
  • Expert Review/Pathology: While not explicitly detailed, trained personnel/experts would be involved in interpreting the histologic slides and radiographic images.
• This is an in vivo biological response and physical measurement ground truth in an animal model, not expert consensus on human images, pathology from human biopsies, or human clinical outcomes data.

8. The Sample Size for the Training Set

• Not Applicable: This device is a physical product (bone void filler), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

• Not Applicable: As above, there is no training set for an AI/ML algorithm for this physical device.

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